NCT01502397

Brief Summary

The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

December 28, 2011

Last Update Submit

September 30, 2019

Conditions

Exposure to Hepatitis B Virus

Keywords

hepatitis Banti-HBcHBsAgrituximaboccult HBV

Outcome Measures

Primary Outcomes (1)

  • HBV reactivation (defined as detectable HBV DNA > 20 IU/mL)

    From date of rituximab commencement up to 2 years

    2 years

Study Arms (1)

HBsAg-negative, anti-HBc-positive

HBsAg-negative, anti-HBc-positive subjects undergoing rituximab-containing chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with B-cell lymphomas or chronic lymphocytic leukaemia referred to Queen Mary Hospital for rituximab-containing chemotherapy

You may qualify if:

  • Documented HBsAg-negative with or without antibody to hepatitis B surface antigen (anti-HBs)
  • Documented anti-HBc (total)-positive

You may not qualify if:

  • Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
  • Significant alcohol intake (\>30 grams per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma for hepatitis B virus genotypic, virologic and serologic testing

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Man-Fung Yuen, FRCP

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2011

First Posted

December 30, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

HK(1)